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510(k) K922432

Device
CHOLERASCREEN
Applicant
NEW HORIZONS DIAGNOSTICS CO.
510(k) number
K922432
Product code
GSQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-07
Date received
1992-05-22
Regulation
866.3930
Classification name
Antiserum, Vibrio Cholerae, All Varieties
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARJORIE I WIER
Address
9110 Red Branch Rd. Suite B Columbia MD US 21045 21045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GSQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954995QUIX RAPID CHOLERA STRIP TESTGuardian Scientific, Corp.1996-08-15
K932622CHOLERA SMART(TM)New Horizons Diagnostics Co.1995-06-27

Legacy Summary#

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FDA Review#

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